Product Description.:
Drops , clear , clear
Colorless to slightly yellow
Latanoprost is a prostaglandin F2α analogue. Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol and octanol. It is practically insoluble in water.
XALATAN Sterile Ophthalmic Solution (latanoprost ophthalmic solution) is supplied as a sterile, isotonic, buffered aqueous solution of latanoprost with a pH of approximately 6.7 and an osmolality of approximately 267 mOsmol/kg. Each mL of XALATAN contains 50 micrograms of latanoprost. Benzalkonium chloride, 0.02% is added as a preservative. The inactive ingredients are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous and water for injection. One drop contains approximately 1.5 ?g of latanoprost.
INDICATIONS
XALATAN Sterile Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Storage
Protect from light. Store unopened bottle(s) under refrigeration at 2? to 8?C (36? to 46?F). During shipment to the patient, the bottle may be maintained at temperatures up to 40?C (104?F) for a period not exceeding 8 days. Once a bottle is opened for use, it may be stored at room temperature up to 25?C (77?F) for 6 weeks.
SIDE EFFECTS
Adverse events referred to in other sections of this insert
Eyelash changes (increased length, thickness, pigmentation, and number of lashes) eyelid skin darkening intraocular inflammation (iritis/uveitis) iris pigmentation changes and macular edema, including cystoid macular edema
DRUG INTERACTIONS
In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with XALATAN. If such drugs are used they should be administered at least five (5) minutes apart.
WARNINGS
XALATAN Sterile Ophthalmic Solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes, and growth of eyelashes. Pigmentation is expected to increase as long as XALATAN is administered. After discontinuation of XALATAN, pigmentation of the iris is likely to be permanent while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The effects of increased pigmentation beyond 5 years are not known.
